UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019235 |
|---|---|
| Receipt number | R000022231 |
| Scientific Title | Effects of splinting for Mallet Finger of the Tendon Origin |
| Date of disclosure of the study information | 2015/10/10 |
| Last modified on | 2015/10/05 12:52:30 |
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Basic information
Public title
Effects of splinting for Mallet Finger of the Tendon Origin
Acronym
Effects of splinting for Mallet Finger of the Tendon Origin
Scientific Title
Effects of splinting for Mallet Finger of the Tendon Origin
Scientific Title:Acronym
Effects of splinting for Mallet Finger of the Tendon Origin
Region
| Japan |
Condition
Condition
mallet finger of tendon origin
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the efficacy of two-step splinting to treat mallet finger of tendon origin, with the first splint immobilizing the finger with the proximal interphalangeal (PIP) joint flexed and the distal interphalangeal (DIP) joint slightly extended, followed by a second splint immobilizing it with the DIP joint extended.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessments were carried out twice: an initial assessment at the first visit, and another at the end of treatment in week 16. The following items were compared between patients in the control group and those treated by two-step splinting: (1) sex, (2) age, (3) injured finger, (4) range of motion (ROM) of active flexion of the DIP joint at the first visit, (5) ROM of active flexion of the DIP joint at the end of treatment, (6) ROM of active extension of the DIP joint at the start of immobilization, (7) ROM of active extension of the DIP joint at the end of treatment, (8) visual analog scale (VAS) pain score at the first visit, (9) VAS pain score at the end of treatment, and (10) outcome (three-grade evaluation according to Abouna and Brown's criteria.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients were divided into two groups, a control group that underwent conventional immobilization with the DIP joint slightly extended,
Interventions/Control_2
and a two-step immobilization group that underwent treatment with an initial first splint that immobilized the finger with the PIP joint flexed and the DIP joint slightly extended, followed by a second splint that immobilized the DIP joint slightly flexed in the conventional manner.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were mallet finger with or without fracture, age 18 years or greater, and treatment with a period of continuous orthosis immobilization for 6 weeks or 8 weeks.
Key exclusion criteria
Exclusion criteria included open lesions, mallet fractures with subluxation of the distal interphalangeal joint (DIP), with delayed treatment of more than 2 weeks,
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Saito |
Organization
Fuchinobe General Hospital
Division name
The departments of Rehabilitation Center
Zip code
Address
3-2-8 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa
TEL
042-754-2222
kasuo_saitoh@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Saito |
Organization
Fuchinobe General Hospital
Division name
The departments of Rehabilitation Center
Zip code
Address
3-2-8 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa
TEL
042-754-2222
Homepage URL
kasuo_saitoh@yahoo.co.jp
Sponsor or person
Institute
Fuchinobe General Hospital
Institute
Department
Personal name
Funding Source
Organization
Fuchinobe General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We found that both, the angle of extension of the DIP joint and pain improved significantly by the end of treatment for all patients in both groups (p<0.001). A comparison between the two groups showed a greater improvement in both, DIP joint extension angle and outcome criteria among patients treated with two-step splinting (p<0.010, p< 0.011).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
Our study thus suggested that the initial immobilization involved in two-step splinting and is thus a good immobilization technique.
Management information
Registered date
| 2015 | Year | 10 | Month | 05 | Day |
Last modified on
| 2015 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022231
